In the digital health scenario typical of the new decade, the electronic product information (ePI) relative to a pharmaceutical product (including the Summary of Product Characteristics and the Product Information leaflet) is still far from being fully implemented and made available to both patients and healthcare professionals. A recent document jointly published by the European medicines Agency (EMA), the Heads of Medicines Agencies (HMA) of EU Member States and the European Commission (EC) addresses the key principles supporting a harmonised approach to develop and use ePI for human medicines across the European Union.

Many new opportunities

The wide availability of digital technologies allows nowadays a capillary and real-time dissemination of the information linked to a certain pharmaceutical product across different platforms, including those directly managed by regulatory bodies. This would prove useful, for example, to rapidly update and distribute ePI with the latest regulatory variations, i.e. should new indications be registered or new adverse effects be included in the informative materials for patients and healthcare professionals. Translations in all the different European languages would also be available without delay. 

Interoperability is one of the main barriers that still limit the diffusion of ePI, an issue which has now been addressed by the document of the European authorities. The pdf version of the product information – the current standard for this type of content – is available through the different platforms, and it is not interoperable with other digital elements typical of the new approach, such as the electronic health records or the e-prescritions. 

The key principles are the result of the work done at the European level, which also included a public consultation run in the first half of 2019 (see here more about the comments received by stakeholders).

The definition of ePI

The document exactly defines the electronic product information as an “authorised, statutory product information for medicines (i.e. SmPC, PL and labelling) in a semi-structured format created using the common EU electronic standard. ePI is adapted for electronic handling and allows dissemination via the world wide web, e-platforms and print”. The key principles outlined by the document are further used to develop its contents, that may include both structured elements (e.g. consistent, fixed headings and controlled vocabularies), and unstructured elements (e.g. free text and graphics). The principles can be used to develop ePI for all human medicines, irrespective of the type of procedure used to reach regulatory approval. 

ePI represents a complimentary element of the European regulatory framework for medicines, which is not altered in any way: the regulatory requirements to be fulfilled for the development of product information remain exactly the same as before. According to the guideline, its aim is only to provide a common technical basis to optimise all fluxes of information and make immediately available all updates on a certain product. The impact expected includes improved awareness in the decision process for both medical doctors and patients, and better compliance to therapies. ePI is also easily readable by automatic systems, thus supporting a better access to information for disabled people. 

A common electronic standard for ePI

The common standard for ePI described in the document includes technical features e.g. the mark-up language, controlled vocabularies and interoperability specifications agreed by EMA, HMA, NCAs, EC, and representatives of the pharmaceutical industry, patients and HCPs. This standard will form the core foundation of the ePI and will prevent the presence of different types of information on the European market. The regulatory process should also benefit in terms of speed to workup variations using data already present in the European databases (e.g. SPOR data). Another expected outcome from the regulatory point of view is the ability to implement changes in product information across all relevant PI annexes and products, thus eliminating many manually performed tasks and redundancies that represent potential sources of error.

The availability of ePI is a public-health priority, states the guideline, as it allows for the dissemination of unbiased, up-to-date, regulator-approved product information for all medicines in the EU. The three European institutions also highlight that ePI is not a promotional material, and cannot be used to provide promotional information. The electronic product information should be always freely available as open data. Further guidance and a roadmap have been announced in order to better describe the ePI implementation process. 

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